COURSE ID 2842

GXP Foundations

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Lucia Mokres

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

GXP represents a collection of regulations and guidelines that encompass best practices for various crucial aspects of medical product development. Due to the intricate regulatory environment and the distinctiveness and diversity of medical product innovations, it can be challenging for sponsors to establish a framework for product development and marketing that satisfies regulatory requirements while accommodating the unique needs of the product.

Apart from ensuring compliance and obtaining regulatory product approval, GXP can also serve as a philosophy for fostering a thriving and effective corporate culture throughout the lifespan of a company, from its establishment to its eventual exit.

This 90-minute accredited training session will focus on essential components of GXP and provide insights into its implementation.

Upon completion of this course, you will be able to:

  • Define GXP
  • Outline some of the key GXP related to medical product development
  • Describe common elements of GXP
  • Explain in general terms how and why GXP is implemented
  • Develop a corporate culture driven by GXP principles
  • Articulate the importance you play in your company, regardless of role
  • Establish a healthy, productive work environment
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This course is intended for professionals within all branches of the regulated medical product sector, including Pharmaceuticals, Biologics, Diagnostics and Medical Device industries. Personnel from entry-level to executive performing in the following positions will find the course valuable:

Clinical: Research Associates, Scientists, Study and Site Monitors, Data Specialists, Trial and Operations Managers

Preclinical: Study Scientists, Technicians and Managers

Quality: Engineers, Associates and Managers

Regulatory: Regulatory professionals, whether you are just learning GXP or are senior level and need a refresher, will find this course useful.

Manufacturing: Technicians, Assembly, Engineers, and Supervisors; Shipping/Receiving

Engineering/R&D: Engineers at all levels, Scientists at all levels

Executive Leadership, especially if you are new to medical product development; are in need of a GXP refresher; or are leading an early stage company and want to establish a quality-oriented corporate culture

Course Instructor

Lucia Mokres

Consultant to the Biotechnology Industry, Doctor of Veterinary Medicine

Lucia Mokres’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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